Home Applications 202835 Application 202835
Type ANDA
Sponsor MYLAN PHARMS INC Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 20MG No No 002 LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 30MG No No 003 LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 40MG No No 004 LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 50MG No No 005 LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 60MG No No 006 LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 70MG No No 007 LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE CAPSULE;ORAL 70MG No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 7 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A202835-001 LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE 10MG CAPSULE / ORAL AB 2023-08-25 A202835-002 LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE 20MG CAPSULE / ORAL AB 2023-08-25 A202835-003 LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE 30MG CAPSULE / ORAL AB 2023-08-25 A202835-004 LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE 40MG CAPSULE / ORAL AB 2023-08-25 A202835-005 LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE 50MG CAPSULE / ORAL AB 2023-08-25 A202835-006 LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE 60MG CAPSULE / ORAL AB 2023-08-25 A202835-007 LISDEXAMFETAMINE DIMESYLATE LISDEXAMFETAMINE DIMESYLATE 70MG CAPSULE / ORAL AB 2023-08-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 7 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-01 22:54:32 2026-06 A202835-001 LISDEXAMFETAMINE DIMESYLATE 10MG CAPSULE / ORAL AB 2023-08-25 a50c72e98297…2026-08-01 22:54:32 2026-06 A202835-002 LISDEXAMFETAMINE DIMESYLATE 20MG CAPSULE / ORAL AB 2023-08-25 a50c72e98297…2026-08-01 22:54:32 2026-06 A202835-003 LISDEXAMFETAMINE DIMESYLATE 30MG CAPSULE / ORAL AB 2023-08-25 a50c72e98297…2026-08-01 22:54:32 2026-06 A202835-004 LISDEXAMFETAMINE DIMESYLATE 40MG CAPSULE / ORAL AB 2023-08-25 a50c72e98297…2026-08-01 22:54:32 2026-06 A202835-005 LISDEXAMFETAMINE DIMESYLATE 50MG CAPSULE / ORAL AB 2023-08-25 a50c72e98297…2026-08-01 22:54:32 2026-06 A202835-006 LISDEXAMFETAMINE DIMESYLATE 60MG CAPSULE / ORAL AB 2023-08-25 a50c72e98297…2026-08-01 22:54:32 2026-06 A202835-007 LISDEXAMFETAMINE DIMESYLATE 70MG CAPSULE / ORAL AB 2023-08-25 a50c72e98297…
Observed Orange Book normalized TE history# openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.